Supporting Statement Part A

Purpose of the data collection: The purpose of this data collection is to assess the feasibility and acceptability of and barriers to implementing the recommendations in the HHS/CDC Community Mitigation Guidelines to Prevent Pandemic Influenza – United States, 2017 that were released as a MMWR-Recommendations and Reports on April 21, 2017. The updated guidelines serve as a pre-pandemic planning tool for state, territorial, and local public health officials. The guidelines include recommendations on the use of non-pharmaceutical interventions (NPIs) in community settings during influenza pandemics.

Intended use of the resulting data: The results will help inform implementation considerations of the guidelines, particularly the feasibility and acceptability issues and barriers that CDC and other partners can help address to strengthen the capacity of state, territorial, and local health departments to implement the guidelines; increase awareness, understanding, and uptake of the NPI recommendations; and facilitate public health stakeholder engagement for future guideline development.

Methods to be used to collect data: A one-time, web-based information collection instrument will be used to collect data.

Respondent universe: Data will be collected from 878 respondents. Acting in their official capacities, respondents will include 59 Directors of Public Health Preparedness of all 50 U.S. states, the District of Columbia (D.C.), and 8 U.S. territories, and a sample of 819 local health department (LHD) preparedness coordinators and/or local health officials (LHOs).

How data will be analyzed: Responses to quantitative, close-ended questions will be analyzed using distributional descriptive statistics (frequencies, means, and ranges). Additional analyses might be needed to compare subgroups, or to examine measurements by strata (small, medium, and large LHDs). Responses to qualitative, open-ended questions will be analyzed thematically. All data will be reported in aggregate.

Section A – Justification

Circumstances Making the Collection of Information Necessary

Background

This information collection is being conducted using the Generic Information Collection mechanism of the OSTLTS OMB Clearance Center (O2C2) – OMB No. 0920-0879. The respondent universe for this information collection aligns with that of the O2C2. Data will be collected from a total of 878 respondents. Acting in their official capacities, respondents will include:

59 Directors of Public Health Preparedness of all 50 U.S. states, the District of Columbia (D.C.), and 8 U.S. territories.
819 local health department (LHD) preparedness coordinators and/or local health officials (LHOs) from 385 small LHDs, 309 medium LHDs, and 125 large LHDs across 47 states (see Attachment A: Respondent Universe and Sample Tables).

This information collection is authorized by Section 301 of the Public Health Service Act (42 U.S.C. 241). This information collection falls under the essential public health service(s) of #3) Informing, educating, and empowering people about health issues, and #5) Development of policies and plans that support individual and community health efforts:

1. Monitoring health status to identify community health problems

2. Diagnosing and investigating health problems and health hazards in the community

3. Informing, educating, and empowering people about health issues

4. Mobilizing community partnerships to identify and solve health problems

5. Development of policies and plans that support individual and community health efforts

6. Enforcement of laws and regulations that protect health and ensure safety

7. Linking people to needed personal health services and assure the provision of health care

when otherwise unavailable

8. Assuring a competent public health and personal health care workforce

9. Evaluating effectiveness, accessibility, and quality of personal and population-based

health services

10. Research for new insights and innovative solutions to health problems¹

The information collection for which approval is sought is in accordance with the mission of the Division of Global Migration and Quarantine (DGMQ), Centers for Disease Control and Prevention (CDC), which is to prevent the introduction, transmission, or spread of communicable diseases within the United States (U.S.) and its territories.

As part of their “all hazards” emergency preparedness and response activities, state, tribal, local, and territorial (STLT) public health departments develop pandemic influenza plans or annexes that include non-pharmaceutical interventions (NPIs) as a critical countermeasure, along with pandemic influenza vaccination and antiviral medications. NPIs also are listed as one of 15 capabilities in the CDC Public Health Preparedness Capabilities: National Standards for State and Local Planning.²

On April 21, 2017, HHS and CDC released updated pre-pandemic planning guidelines entitled Community Mitigation Guidelines to Prevent Pandemic Influenza – United States, 2017.³ The updated guidelines encourage STLT public health officials to plan and prepare for implementing NPIs early in an influenza pandemic in community settings; summarize key lessons learned from the 2009 H1N1 pandemic response; describe new or updated pandemic planning and assessment tools; and provide the latest scientific findings to support updated recommendations on the use of NPIs to help slow the spread and decrease the impact of an influenza pandemic.

The 2017 guidelines delineate NPIs into 2 categories: 1) NPIs recommended at all times, and 2) NPIs reserved for influenza pandemics. Categories of NPIs recommended at all times and in all settings include personal protective measures for everyday use (voluntary home isolation of ill persons, respiratory etiquette, and hand hygiene) and environmental surface cleaning measures (routine cleaning of frequently touched surfaces and objects). During an influenza pandemic, these NPIs will be recommended regardless of the pandemic severity level. Categories of NPIs reserved for influenza pandemics include personal protective measures (voluntary home quarantine of exposed household members, and use of facemasks in community settings when ill) and community measures aimed at increasing social distancing (temporarily closing or dismissing schools⁴, limiting face-to-face contact in workplaces, and postponing or cancelling mass gatherings). During an influenza pandemic, these additional personal and community NPIs might be recommended depending on the overall pandemic severity and local conditions.

Local decisions about the selection and timing of NPIs reserved for influenza pandemics will require flexibility and modification as a pandemic progresses and new information becomes available. As part of their ongoing pandemic influenza planning and preparedness activities, STLT public health officials will need to consider how to put the updated recommendations for NPIs reserved for influenza pandemics into practice in their communities.

This information collection will focus specifically on implementation of the above-mentioned NPIs reserved for influenza pandemics during a severe pandemic, and will assess 3 important considerations when implementing these NPIs in state, territorial, and local public health jurisdictions: 1) the feasibility of implementing the NPI recommendations, 2) the level of acceptability of the NPI recommendations, and 3) the barriers to implementing the NPI recommendations (see Attachment B: NPIs Reserved for Influenza Pandemics Table).

The resulting data will be summarized and presented in a comprehensive summary report. The report will identify issues raised by the respondents with respect to the feasibility and acceptability of implementing the NPI recommendations during severe influenza pandemics; and highlight expressed barriers to implementing the NPI recommendations in community settings. The resulting data also will be used to update sections of the 2017 Community Mitigation Guidelines, as needed. This new information collection will help inform implementation considerations of the guidelines, particularly the feasibility and acceptability issues and barriers that CDC and other partners can help address to strengthen the capacity of state, territorial, and local health departments to implement the guidelines; increase awareness, understanding, and uptake of the NPI recommendations; and facilitate public health stakeholder engagement for future guideline development.

A task order contractor (The MayaTech Corporation) and the National Association of County and City Health Officials (NACCHO), funded through a cooperative agreement (OT18-1802), will both support this data collection in varying capacities. Additionally, to help support the goals and objectives of this data collection effort, a 15-member Stakeholder Engagement Group (SEG) was established with representatives from the Association of State and Territorial Health Officials (ASTHO), Council of State and Territorial Epidemiologists (CSTE), NACCHO, and National Public Health Information Coalition (NPHIC). The SEG members helped identify lists of prospective recipients of the online assessment tool; determine appropriate recipient sampling methods; improve the clarity of the draft assessment questions; and define the best approach for conducting the online assessment to generate strong response rates.

Overview of the Information Collection System

Data will be collected from a universe of 878 state, territorial, and local health department officials comprised of 59 Directors of Public Health Preparedness of all 50 U.S. states, D.C., and 8 U.S. territories, and a stratified random sample of 819 LHD preparedness coordinators and/or local health officials (LHOs). Data will be collected via a web-based online instrument using SurveyMonkey for the Directors of Public Health Preparedness and using Qualtrics for the LHD preparedness coordinators and/or LHOs (see Attachment C: Instrument Word Version, Attachment D: Instrument Web Version [using SurveyMonkey], and Attachment E: Instrument Web Version [using Qualtrics]).

The information collection instrument was pilot tested by 8 public health professionals. Feedback from this group was used to clarify definitions and instructions provided; refine questions as needed; ensure accurate programming, skip patterns, and adequacy of the scale; and establish the estimated time required to complete the information collection instrument.

Items of Information to be Collected

The data collection instrument consists of 42 main questions of various types and mixed formats, including close-ended questions (e.g., yes/no/do not know/not sure); four-point, ordinal Likert scales to prevent neutral ratings (e.g., high feasibility to low feasibility); and open-ended questions (e.g., describe the perceived barriers in your jurisdiction). The 42 main questions cover the following 4 topic areas:

Background Information on Respondent and Jurisdiction(s) asks the instrument recipient 4 brief background questions about their jurisdiction.
Status of Pre-pandemic Planning in Your Jurisdiction asks the instrument recipient 8 questions about their jurisdiction’s progress in planning for an influenza pandemic, and in incorporating the 2017 Community Mitigation Guidelines in their pandemic influenza preparedness plan.
Feasibility and Acceptability of Implementing NPI Recommendations in Your Jurisdiction asks the instrument recipient 24 questions about the feasibility and acceptability of and barriers to implementing the 4 NPIs reserved for influenza pandemics – voluntary home quarantine, use of face masks by ill persons, school closures and dismissals, and social distancing at schools, workplaces, and mass gatherings – in their jurisdiction.
Potential Triggers to Activate NPIs in Your Jurisdiction asks the instrument recipient 6 questions about influenza surveillance indicators and data sources that their jurisdiction would use for triggering implementation of the above-mentioned NPIs before the explosive growth of an influenza pandemic in their jurisdiction.

Purpose and Use of the Information Collection

The purpose of this information collection is to assess the feasibility and acceptability of and barriers to implementing the recommendations in the HHS/CDC Community Mitigation Guidelines to Prevent Pandemic Influenza – United States, 2017 that were released as a MMWR-Recommendations and Reports in April 2017. The recommendations relate to the use of non-pharmaceutical interventions (NPIs) in community settings during influenza pandemics.

There are 2 categories of NPIs: 1) those recommended at all times, and 2) those reserved for influenza pandemics. This data collection focuses on NPIs reserved for influenza pandemics, which include personal protective measures (voluntary home quarantine of exposed household members, and use of facemasks in community settings when ill) and community measures aimed at increasing social distancing (temporarily closing or dismissing schools, limiting face-to-face contact in workplaces, and postponing or cancelling mass gatherings).

This information collection will focus specifically on implementation of the above-mentioned NPIs reserved for influenza pandemics during a severe pandemic and will assess 3 important considerations when implementing these NPIs in state, territorial, and local public health jurisdictions: 1) the feasibility of implementing the NPI recommendations, 2) the level of acceptability of the NPI recommendations, and 3) the barriers to implementing the NPI recommendations.

Use of Improved Information Technology and Burden Reduction

Data will be collected via a web-based online instrument allowing respondents to complete and submit their responses electronically. This method was chosen to reduce the overall burden on respondents by allowing for auto-skipping when an item does not apply and as a means by which respondents can contribute to the assessment without arduous tracking of file versions. Respondents can open the online assessment, save it as needed, and return to it for completion and submission at their convenience.

The data collection instrument was designed to collect the minimum information necessary for the purposes of this project (i.e., limited to 42 main questions). Most questions require selection of one response using a close-ended format, or selection of a rating response using a Likert-type scale. When “other” or “please explain” type questions are used, space is provided for open-ended responses to give the instrument recipients an opportunity to elaborate on or explain their ratings. An effort was made to limit the number of questions requiring narrative responses from the recipients whenever possible.

Efforts to Identify Duplication and Use of Similar Information

Previous CDC-funded efforts to collect data from public health officials on the use of community mitigation strategies (or NPIs) during influenza pandemics, or to collect data from a similar respondent universe of Directors of Public Health Preparedness, Public Health Emergency Preparedness (PHEP) directors, and/or preparedness coordinators were reviewed prior to the development of this information collection. Reviews included both internal to CDC and external data collections and reports. Results of this review determined that this information collection is non-duplicative of past or planned collections.

Impact on Small Businesses or Other Small Entities

No small businesses will be involved in this information collection.

Consequences of Collecting the Information Less Frequently

This request is for a one-time data collection. There are no legal obstacles to reduce the burden. If no data are collected, CDC will be unable to:

Identify issues raised by state, territorial, and local public health officials with respect to the feasibility (capability) of implementing the NPI recommendations during severe influenza pandemics;
Identify issues raised by public health officials regarding the level of acceptability of (compliance with) the NPI recommendations by community stakeholders and partners;
Highlight expressed barriers to implementing the NPI recommendations in community settings by public health officials; and
Update sections of the 2017 Community Mitigation Guidelines, as needed, to enhance the usefulness of the guidelines for pre-pandemic planning.

Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances with this data collection package. This request fully complies with the regulation 5 CFR 1320.5 and will be voluntary.

Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

This data collection is being conducted using the Generic Information Collection mechanism of the OSTLTS OMB Clearance Center (O2C2) – OMB No. 0920-0879. A 60-day Federal Register Notice was published in the Federal Register on April 27, 2017, Vol. 82, No. 80, pp 19371-19373. One non-substantive comment was received. CDC sent forward the standard CDC response.

CDC partners with professional STLT organizations, such as the Association of State and Territorial Health Officials (ASTHO), the National Association of County and City Health Officials (NACCHO), and the National Association of Local Boards of Health (NALBOH) along with the National Center for Health Statistics (NCHS) to ensure that the collection requests under individual ICs are not in conflict with collections they have or will have in the field within the same timeframe.

Explanation of Any Payment or Gift to Respondents

CDC will not provide payments or gifts to respondents.

Protection of the Privacy and Confidentiality of Information Provided by Respondents

The Privacy Act does not apply to this data collection. STLT governmental staff will be speaking from their official roles.

Institutional Review Board (IRB) and Justification for Sensitive Questions

No information will be collected that are of personal or sensitive nature. This data collection is not research involving human subjects.

Estimates of Annualized Burden Hours and Costs

The estimate for burden hours is based on a pilot test of the online data collection instrument by 8 public health professionals. In the pilot test, the average time to complete the instrument including time for reviewing instructions, gathering needed information, and completing the instrument, was approximately 51 minutes (range: 24–90 minutes). For the purposes of estimating burden hours, the upper limit of this range (i.e., 90 minutes) is used.

Estimates for the average hourly wage for respondents are based on the Department of Labor (DOL) Bureau of Labor Statistics for occupational employment for emergency management directors or environmental scientists and specialists, including health (http://www.bls.gov/oes/current/oes_nat.htm). Based on DOL data, an average hourly wage of $39.01 is estimated for 59 respondents and $36.64 is estimated for 819 respondents. Table A-12 shows estimated burden and cost information.

Table A-12: Estimated Annualized Burden Hours and Costs to Respondents

Data Collection Instrument: Form Name	Type of Respondent	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours	Average Hourly Wage Rate	Total Respondent Costs
Online Assessment Tool	Director of Public Health Prepared-ness in state, territorial, and D.C. HDs	59	1	90 / 60	89	$39.01	$3,472
Online Assessment Tool	Prepared-ness Coor- dinator or Local Health Official in local HDs	819	1	90 / 60	1,229	$36.64	$45,031
	TOTALS	878	1		1,318		$48,503

Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There will be no direct costs to the respondents other than their time to participate in each data collection.

Annualized Cost to the Government

There are no equipment or overhead costs. The only cost to the federal government will be the salary of CDC project staff, and the costs of a task order contractor – the MayaTech Corporation and a cooperative agreement awardee – NACCHO – to implement this new information collection. Staff from CDC, the MayaTech Corporation, and NACCHO will support the tasks outlined below in Table A-14. The total estimated cost to the federal government is $215,841. Table A-14 describes how this cost estimate was calculated.

Table A-14: Estimated Annualized Cost to the Federal Government

Staff	Average Hours per Collection	Average Hourly Rate	Total Average Cost
CDC Senior Epidemiologist – GS-14, Step 10: Project Co-Lead Co-lead and facilitate project activities Provide technical subject matter expert (SME) review and feedback on project-related documents Prepare documents and manage OMB process Review and interpret data tabulations and findings Contribute to summary report	608	$67.45/hour	$41,010
CDC Senior Health Scientist – GS-14, Step 10: Project Co-Lead Co-lead and facilitate project activities Provide technical SME review and feedback on project-related documents Prepare documents and manage OMB process Review and interpret data tabulations and findings Contribute to summary report	608	$67.45/hour	$41,010
CDC Mathematical Statistician – GS-14, Step 3: Provide technical SME review and feedback on statistical aspects of data collection and analysis	16	$55.34/hour	$885
Task Order Contractor (4 people) – The MayaTech Corporation: Develop public health stakeholder engagement strategy Develop technical approach/protocol Draft, pilot, and finalize data collection instrument (online assessment tool) Distribute online assessment tool (using SurveyMonkey) and collect data from selected state/territorial public health officials Develop data dictionary and database Perform data analyses Complete comprehensive summary report			$94,185
Cooperative Agreement Awardee (4 people)– NACCHO Establish criteria for identifying local health departments and prospective recipients of online assessment tool Develop and implement approach and timeline for contacting prospective recipients Distribute online assessment tool (using Qualtrics) and collect data from selected local public health officials Submit dataset to MayaTech Corporation Create brief summary report			$38,751
Estimated Total Cost of Information Collection			$215,841

Explanation for Program Changes or Adjustments

This is a new data collection.

Plans for Tabulation and Publication and Project Time Schedule

Data collected during the assessment will be kept on secure, password-protected servers accessible only to the MayaTech Corporation and NACCHO project team members. The MayaTech Corporation will develop a database of all quantitative and qualitative data collected and a data dictionary (catalogue or codebook) of the data variables, types, level of measurement, and value labels. The MayaTech Corporation also will conduct a structured data cleaning process in SPSS to check for errors, and prepare a report of all errors found. At the completion of the project, the MayaTech Corporation will provide the data dictionary and database to CDC. CDC will own the data dictionary, data collected, and database as well as a comprehensive summary report.

The quantitative data collected will be analyzed by the MayaTech Corporation using distributional descriptive statistics (e.g., frequencies, means, and ranges). Additional analyses might be needed to compare subgroups of the population, or to examine measurements by strata (e.g., small, medium, and large LHDs). Responses to qualitative, open-ended questions will be analyzed thematically. The qualitative, semi-structured responses will be entered into a qualitative analysis software (e.g., Atlas.ti, Dedoose, Nvivo, or QSR Nud*ist), which will assist in the identification and analysis of similar themes across all of the respondents. Cross-cutting themes that emerge will help highlight priority areas for future capacity-building efforts related to NPI pre-pandemic planning and preparedness.

The analysis of the data collected will be summarized and presented in a comprehensive summary report. At the completion of the project, the MayaTech Corporation will submit the summary report to CDC. Plans for dissemination and/or publication of the findings include providing key public health partners (ASTHO, CSTE, NACCHO, and NPHIC) with a topline report (or webinar) to update them on the overall findings and next steps; presenting the findings at select public health conferences like NACCHO’s annual Preparedness Summit; and publishing the findings in a peer-reviewed journal.

In addition, the collected data will be used to identify issues raised by the respondents with respect to the feasibility and acceptability of implementing the NPI recommendations during severe influenza pandemics; highlight expressed barriers to implementing the NPI recommendations in community settings; and update sections of the 2017 Community Mitigation Guidelines, as needed. This new information collection also will help inform implementation considerations of the guidelines, particularly the feasibility and acceptability issues and barriers that CDC and other partners can help address to strengthen the capacity of state, territorial, and local health departments to implement the guidelines; increase awareness, understanding, and uptake of the NPI recommendations; and facilitate public health stakeholder engagement for future guideline development.

Project Time Schedule

Design instrument (COMPLETE)

Develop protocol, instructions, and analysis plan (COMPLETE)

Pilot test instrument (COMPLETE)
Prepare OMB package (COMPLETE)
Submit OMB package (COMPLETE)

OMB approval (TBD)
Conduct data collection (Open 4 weeks)
Code data, conduct quality control, and analyze data (2-3 months)
Prepare summary report(s) (1-2 months)
Disseminate results/reports (4-6 months)

Reason(s) Display of OMB Expiration Date is Inappropriate

We are requesting no exemption.

Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification. These activities comply with the requirements in 5 CFR 1320.9.

LIST OF ATTACHMENTS – Section A

Attachment A: Respondent Universe and Sample Tables

Attachment B: NPIs Reserved for Influenza Pandemics Table

Attachment C: Instrument Word Version

Attachment D: Instrument Web Version (using SurveyMonkey)

Attachment E: Instrument Web Version (using Qualtrics)

REFERENCE LIST

Centers for Disease Control and Prevention (CDC). "National Public Health Performance Standards Program (NPHPSP): 10 Essential Public Health Services." Available at: https://www.cdc.gov/stltpublichealth/publichealthservices/essentialhealthservices.html
Centers for Disease Control and Prevention (CDC), Office of Public Health Preparedness and Response (OPHPR). Public Health Preparedness Capabilities: National Standards for State and Local Planning. 2011 March; 1-152. Available at: https://www.cdc.gov/phpr/readiness/00_docs/DSLR_capabilities_July.pdf
Qualls N, Levitt A, Kanade N, et al. Community Mitigation Guidelines to Prevent Pandemic Influenza – United States, 2017. Morbidity and Mortality Weekly Report. Recommendations and Reports. 2017; 66(1):1-34. Available at: https://www.cdc.gov/mmwr/volumes/66/rr/pdfs/rr6601.pdf
U.S. Community Preventive Services Task Force (USCPSTF). Emergency Preparedness and Response: School Dismissals to Reduce Transmission of Pandemic Influenza [The Community Guide Systematic Review]. 2012 August. Available at:

https://www.thecommunityguide.org/findings/emergency-preparedness-and-response-school-dismissals-reduce-transmission-pandemic-influenza

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